The Council for Responsible Nutrition (CRN), Washington, D.C., has urged the U.S. District Court in New Jersey to hold the Federal Trade Commission (FTC) to the flexible “competent and reliable scientific evidence” standard for review of dietary supplement advertising. The brief addresses a motion by the U.S. Department of Justice on behalf of the FTC, with respect to Bayer Healthcare’s advertising claims for its Phillips’ Colon Health probiotic supplement.

CRN’s brief argued that by requiring multiple randomized, double-blind, placebo-controlled, human clinical trials using the specific product for which the claims are made and are performed in the population at which the claims are directed, the FTC is invoking “a rigid standard for the substantiation of non-disease claims made about dietary supplements that is a significant departure from the current well-established, consistent and flexible federal regulatory regime upon which the entire dietary supplement industry has long relied.”

The brief further outlined the negative consequences that would come as a result of the government overreaching its authority, saying the change “would significantly impair the flow of truthful, valuable, and scientifically sound information about dietary supplement products and limit consumers’ ability to make fully-informed nutrition-related decisions.” The standard of substantiation proposed by the FTC would impose drug-like requirements on dietary supplements that go far beyond what Congress intended and would effectively apply the medically-based, treatment-focused regulatory framework for drugs to dietary supplements. The evaluation of structure-function claims would essentially be treated the same as disease claims, which is contrary to the intent of the law.

“We are concerned that, if successful, FTC’s attempt to impose this legally-unprecedented review of advertising claims for supplements could eliminate many structure-function claims and disregard a wealth of rigorous scientific data that does not meet the narrow drug-like requirements,” said Steve Mister, president & CEO, CRN. “It would chill the First Amendment rights of manufacturers, marketers and consumers to communicate and to receive truthful information about the health benefits of these products.”

The Natural Products Association (NPA), Washington, D.C., also filed an amicus brief with the U.S. Supreme Court and the U.S. Attorney’s Office for the District of New Jersey that challenged the legal action taken by FTC and DOJ.

The government filed an order on Sept. 12 in the U.S. District Court of New Jersey, claiming the company violated an earlier 2007 consent agreement surrounding the claim that its One-A-Day WeightSmart supplement would increase metabolism.

The current Phillips’ Colon Health product under scrutiny makes the claim to defend against occasional constipation, diarrhea and gas and bloating. According to NPA, these types of claims are sufficiently qualified and limited in scope to declaim any implied disease origins as structure/function claims permitted under the Jan. 6, 2000 Structure/Function Final Rule, which was written exclusively for dietary supplements.

“There is no legal basis at present for the government to require one or multiple RCTs as the only accepted form of evidence for claim substantiation,” NPA noted. “If the government was correct in its assertion that such RCTs should be required in all cases, entire shelves at drug stores would become bare.”

Daniel Fabricant, PhD, NPA executive director and CEO, added: “NPA is very concerned that the government is using consent orders to effectively re-write federal law on dietary supplements. It’s important to point out that consent orders, which are meant to be case specific, may have unintended consequences for consumers if applied across the industry. Those include not just increased costs, but also the possibility of the reduced quality and quantity of information about products available to consumers.

We urge the court to carefully consider this case and recognize that the outcome could result in major consequences for consumers, retailers and manufacturers of dietary supplements.”

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